Abstract
Objective
To evaluate the effect of a 6-week washout period on intraocular pressure (IOP) following
long-term monotherapy prostaglandin use.
Design
Prospective, randomized, controlled, single-centre, single-blinded, parallel-group
clinical study.
Participants
Subjects aged >18 years diagnosed with open-angle glaucoma or open-angle glaucoma
suspects based on elevated IOP in one or both eyes, using monotherapy topical latanoprost,
bimatoprost, or travoprost once daily.
Methods
Subjects were prospectively randomized to continue prostaglandin analogue (PGA) monotherapy
(control group) or discontinue PGA monotherapy (washout group) for 42 days. IOP was
measured at day 0 (day of randomization), 7, 21, and 42.
Main Outcome Measure
Mean IOP (mm Hg) ± standard deviation.
Results
154 eyes (87 participants) completed the study, with 69 eyes (39 participants) in
the control group and 85 eyes (48 participants) in the washout group. In the control
group, day 0 IOP (14.64 ± 2.68 mm Hg) did not significantly differ from IOP at days
7 (14.25 ± 3.01 mm Hg), 21 (14.57 ± 2.61 mm Hg), and 42 (14.78 ± 2.30 mm Hg) (all
p > 0.30). In the washout group, mean IOP values at days 7 (16.19 ± 3.80 mm Hg), 21
(17.28 ± 3.55 mm Hg), and 42 (17.84 ± 3.31 mm Hg) were significantly greater than
those at day 0 (14.48 ± 1.94 mm Hg) and day-matched control group values (all p < 0.002). In the washout group, 24.7% of eyes had a day 42 IOP ≥21 mm Hg. No eyes
in the control group had a day 42 IOP ≥21 mm Hg.
Conclusions
Six weeks of PGA washout after long-term monotherapy resulted in a small but statistically
significant IOP increase. Majority of washout group participants maintained an IOP
lower than 21 mm Hg after the 6-week washout duration. (https://clinicaltrials.gov/ identifier, NCT03534882)
Résumé
Objectif
Évaluer l'effet d'un congé thérapeutique de 6 semaines sur la pression intraoculaire
(PIO) dans le cadre de l'administration à long terme d'une prostaglandine en monothérapie.
Nature
Étude clinique prospective, comparative, randomisée à simple insu et à groupes parallèles
réalisée dans un seul centre.
Participants
Des sujets âgés > 18 ans qui ont fait l'objet d'un diagnostic de glaucome à angle
ouvert ou chez lesquels on soupçonnait la présence d'un tel glaucome en raison de
la hausse de la PIO dans un œil ou les 2 yeux et qui instillaient un collyre (latanoprost,
bimatoprost ou travoprost) en monothérapie une fois par jour.
Méthodes
Les patients ont fait l'objet d'une randomisation prospective en 2 groupes : poursuite
de l'administration de l'analogue de la prostaglandine (APG) à titre de monothérapie
(groupe témoin) ou cessation de l'APG en monothérapie (groupe congé thérapeutique)
pendant 42 jours. La PIO a été mesurée au jour 0 (jour de la randomisation) de même
qu'aux jours 7, 21 et 42.
Principal paramètre de mesure
PIO moyenne (mm Hg) ± écart-type.
Résultats
Au total, 87 participants (154 yeux) ont poursuivi l’étude jusqu’à la fin : 39 participants
(69 yeux) dans le groupe témoin et 48 participants (85 yeux) dans le groupe congé
thérapeutique. Au jour 0, la PIO dans le groupe témoin (14,64 ± 2,68 mm Hg) ne différait
pas significativement de la PIO mesurée le jour 7 (14,25 ± 3,01 mm Hg), le jour 21
(14,57 ± 2,61 mm Hg) et le jour 42 (14,78 ± 2,30 mm Hg; p > 0,30 pour l'ensemble des
mesures). En revanche, la PIO moyenne dans le groupe congé thérapeutique mesurée au
jour 7 (16,19 ± 3,80 mm Hg), au jour 21 (17,28 ± 3,55 mm Hg) et au jour 42 (17,84
± 3,31 mm Hg) était significativement supérieure à la PIO enregistrée au jour 0 (14,48
± 1,94 mm Hg) et à la PIO mesurée les mêmes jours dans le groupe témoin (p < 0,002
pour l'ensemble des mesures). Dans le groupe congé thérapeutique, la PIO de 24,7 %
des yeux se chiffrait à ≥ 21 mm Hg au jour 42. Aucun œil du groupe témoin n'a atteint
une PIO ≥ 21 mm Hg au jour 42.
Conclusions
L'arrêt d'un APG pendant 6 semaines dans le cadre d'une monothérapie de longue durée
a entraîné une hausse faible, mais statistiquement significative de la PIO. La majorité
des patients du groupe congé thérapeutique ont conservé une PIO inférieure à 21 mm
Hg après les 6 semaines de cessation du traitement. (https://clinicaltrials.gov/; numéro d’étude : NCT03534882)
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Canadian Journal of OphthalmologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Canadian Ophthalmological Society evidence-based clinical practice guidelines for the management of glaucoma in the adult eye.Can J Ophthalmol. 2009; 44 Suppl 1: S7-93
National Institute for Health and Care Excellence (NICE). Glaucoma: diagnosis and management guidelines 2017. https://www.nice.org.uk/guidance/ng81(accessed September 8, 2018).
- Primary Open-Angle Glaucoma Preferred Practice Pattern Guidelines.American Academy of Ophthalmology, San Francisco, CA2015
- Comparative effectiveness of first-line medications for primary open-angle glaucoma: a systematic review and network meta-analysis.Ophthalmology. 2016; 123: 129-140
- A 5-year, randomized, open-label safety study of latanoprost and usual care in patients with open-angle glaucoma or ocular hypertension.Eur J Ophthalmol. 2008; 18: 408-416
- Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost.Surv Ophthalmol. 2001; 45 Suppl 4: S353-S360
- Safety and efficacy of travoprost solution for the treatment of elevated intraocular pressure.Clin Ophthalmol. 2015; 9: 633-643
- Projected cost comparison of selective laser trabeculoplasty versus glaucoma medication in the Ontario Health Insurance Plan.Can J Ophthalmol. 2006; 41: 449-456
- Medical management of glaucoma in the 21st century from a Canadian perspective.J Ophthalmol. 2016; 20166509809
- Update on the mechanism of action of topical prostaglandins for intraocular pressure reduction.Surv Ophthalmol. 2008; 53: S107-S120
- Prostaglandin FP agonists alter metalloproteinase gene expression in sclera.Invest Opthalmol Vis Sci. 2004; 45: 4368
- A review of the use of latanoprost for glaucoma since its launch.Expert Opin Pharmacother. 2012; 13: 723-745
- Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension.Drugs Aging. 2009; 26: 1049-1071
- Latanoprost as a new horizon in the medical management of glaucoma.Curr Opin Ophthalmol. 1996; 7: 11-17
- The effect of latanoprost on intraocular pressure during 2 years of treatment.Surv Ophthalmol. 2002; 47 Suppl 1: S65-S76
- Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning. A comparison with timolol. Scandinavian Latanoprost Study Group.Ophthalmology. 1995; 102: 1743-1752
- Ocular hypotensive effect of PhXA41 in patients with ocular hypertension or primary open-angle glaucoma.Jpn J Ophthalmol. 1993; 37: 270-274
- Intraocular pressure-reducing effect of PhXA41 in ocular hypertension: comparison of dose regimens.Ophthalmology. 1993; 100: 1305-1311
- Clinical dose-regimen studies with latanoprost, a new ocular hypotensive PGF2 alpha analogue.Surv Ophthalmol. 1997; 41 Suppl 2: S77-S81
- Effectiveness of intraocular pressure-lowering medication determined by washout.JAMA Ophthalmol. 2014; 132: 390-395
- Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure.Clin Ther. 2004; 26: 84-91
- Sustained effect of travoprost on diurnal and nocturnal intraocular pressure.Am J Ophthalmol. 2006; 141: 1131-1133
- The efficacy and safety of once-daily versus once-weekly latanoprost treatment for increased intraocular pressure.J Ocul Pharmacol Ther. 2004; 20: 321-327
- Effects on IOP restoration and blood-aqueous barrier after long-term treatment with latanoprost in open angle glaucoma and ocular hypertension.Br J Ophthalmol. 1997; 81: 370-372
- Washout periods for brimonidine 0.2% and latanoprost 0.005%.Am J Ophthalmol. 2001; 131: 798-799
- Washout duration of prostaglandin analogues: a systematic review and meta-analysis.J Ophthalmol. 2018; 20183190684
- A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study.Am J Ophthalmol. 2003; 135: 688-703
- GLIMMPSE: online power computation for linear models with and without a baseline covariate.J Stat Softw. 2013; 54: i10
- A randomized double-masked crossover study comparing latanoprost 0.005% with unoprostone 0.12% in patients with primary open-angle glaucoma and ocular hypertension.Am J Ophthalmol. 2001; 131: 636-642
- Intraocular pressure over 24 hours after repeated administration of latanoprost 0.005% or timolol gel-forming solution 0.5% in patients with ocular hypertension.Ophthalmology. 2001; 108: 1439-1444
- The impact of intraocular pressure reduction on retinal ganglion cell function measured using pattern electroretinogram in eyes receiving latanoprost 0.005% versus placebo.Vis Res. 2011; 51: 235-242
- Effects of prostaglandin analogues on aqueous humor outflow pathways.J Ocul Pharmacol Ther. 2014; 30: 102-109
- Effects of prostaglandins on the aqueous humor outflow pathways.Surv Ophthalmol. 2002; 47 Supplement 1: S53-S64
- Morphological changes in the anterior eye segment after long-term treatment with different receptor selective prostaglandin agonists and a prostamide.Invest Ophthalmol Vis Sci. 2003; 44: 4419-4426
- Effects of long-term topical prostaglandin therapy on central corneal thickness.J Ocul Pharmacol Ther. 2014; 30: 440-444
- Decreased keratocyte density and central corneal thickness in primary open-angle glaucoma patients undergoing treatment with topical prostaglandin analogues.Indian J Ophthalmol. 2015; 63: 15-19
- Effect of corneal thickness on intraocular pressure measurements with the pneumotonometer, Goldmann applanation tonometer, and Tono-Pen.Invest Ophthalmol Vis Sci. 2002; 43: 1389-1392
Article info
Publication history
Published online: November 08, 2019
Accepted:
August 29,
2019
Received in revised form:
July 1,
2019
Received:
May 12,
2019
Footnotes
Presented at the Canadian Ophthalmology Society Annual Meeting, Ottawa, Ontario, Canada, June 18, 2016, American Glaucoma Society annual Meeting, Fort Lauderdale, Florida, USA, March 3, 2016.
Identification
Copyright
© 2019 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.
